Product News

Published Online: Monday, December 1, 2008
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Alendronate Sodium Tablets

Marketed by:
Sun Pharmaceutical Industries (Mumbai, India)

Compared to:
Fosamax (Merck & Co)

Indication:
September 12, 2008—Sun Pharmaceutical Industries Ltd announced that the FDA granted final approval for the company's abbreviated new drug application for Alendronate Sodium Tablets. Alendronate Sodium Tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoidinduced osteoporosis, and Paget's disease of the bone in men and women.

Dosage Form:
Tablets: 5, 10, 35, and 70 mg (base)

For More Information:
www.sunpharma.com



Azithromycin for Oral Suspension USP

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to:
Zithromax for Oral Suspension (Pfizer Inc)

Indication:
September 22, 2008—Teva Pharmaceuticals announced the introduction and availability of Azithromycin for Oral Suspension USP. It is AB-rated and bioequivalent to Zithromax for Oral Suspension. The product is indicated for the treatment of patients with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in conditions such as acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Dosage Form:
Oral suspension: 100 mg/5 mL in 15-mL bottles and 200 mg/5 mL in 15-, 22.5-, and 30-mL bottles

For More Information:
www.tevausa.com
888-TEVA USA (888-838-2872)



Calcium Acetate Capsules

Marketed by:
Roxane Laboratories Inc (Columbus, OH)

Compared to:
PhosLo capsules (Fresenius Medical Care)

Indication:
October 15, 2008—Roxane Laboratories Inc announced the FDA approval of its abbreviated new drug application for Calcium Acetate Capsules, 667 mg. Calcium Acetate Capsules are indicated for the control of hyperphosphatemia in end-stage renal failure and do not promote aluminum absorption. The product is contraindicated in patients with hypercalcemia. The recommended initial dose of calcium acetate capsules for the adult dialysis patient is 2 capsules with each meal.

Dosage Form:
Capsules: 667 mg

For More Information:
www.roxane.com
800-962-8364



Carbidopa and Levodopa Orally Disintegrating Tablets

Marketed by:
Mylan Inc (Pittsburgh, PA)

Compared to:
Parcopa ODT (Schwarz Pharma)

Indication:
September 22, 2008—Mylan Inc announced that its subsidiary, Mylan Pharmaceuticals Inc, received final FDA approval for its abbreviated new drug application for Carbidopa and Levodopa Orally Disintegrating Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg. These tablets are in the category of an antiparkinsonian agent and are indicated for the treatment of idiopathic Parkinson's disease. Carbidopa and Levodopa Orally Disintegrating Tablets are administered orally and rapidly disintegrate on the tongue and do not require water to aid dissolution or swallowing.

Dosage Form:
Tablets: 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg

For More Information:
www.mylan.com




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